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Non Small Cell Lung CancerPhase 2NCT04405674

Tislelizumab Combined With Chemotherapy With or Without Bevacizumab in TKI-Resistant EGFR-Mutated Non-squamous NSCLC

A Phase 2 study testing Tislelizumab, Carboplatin and Pemetrexed in people with Non Small Cell Lung Cancer, run by Shanghai Chest Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A phase II, open-label, multicenter, two cohorts, prospective clinical study to investigate the efficacy and safety of tislelizumab (anti-pd1 antibody) combined with chemotherapy with or without bevacizumab in non-squamous non-small cell lung cancer patients with EGFR sensitizing mutation who failed EGFR TKI… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Tislelizumab, Carboplatin and Pemetrexed
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
15 Jul 2020to Mar 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed, locally advanced (Stage IIIB/C) not amenable to curative surgery or radiotherapy, or metastatic (Stage IV) non-squamous NSCLC according to American Joint Committee on Cancer, 8th Edition.
  • Documentation of tumor EGFR sensitizing mutation before EGFR TKI treatment, including 19del, L858R, G719X, S786I and L861Q.
  • Disease progression after treatment with an EGFR TKI therapy: 1) Patients previously treated with 1st or 2nd generation EGFR TKI (e.g. erlotinib/afatinib/gefitinib/icotinib) are required to provide specimens after PD to confirmed absence of EGFR T790M mutation; 2) Patients with confirmed acquired T790M mutation after 1st or 2nd generation EGFR TKI (e.g. erlotinib/afatinib/gefitinib/icotinib) are required to have 3rd generation EGFR TKI (e.g. osimertinib) treatment failure prior to enrollment; 3) Patients previously failed from 3rd generation EGFR TKI (e.g. osimertinib) treatment as 1st line therapy are eligible regardless of their EGFR T790M mutation status.
  • ECOG (Eastern Cooperative Oncology Group) performance status ≤ 1.
  • Life expectancy ≥ 3 months.
  • Adequate organ function
  • Able to provide written informed consent by the patient or by the patient's legally acceptable representative and can understand and agree to comply with the requirements of the study.
  • 18 to 75 years old on the day of signing the ICF (Informed Consent Form).

Who cannot join

  • Received prior therapies targeting PD-1, PD-L1, CTLA-4 or other immune checkpoints.
  • Received prior platinum-based chemotherapy for advanced disease.
  • Patients who have received prior systemic anti-vascular therapy (e.g., bevacizumab and small molecule VEGFR inhibitors) for advanced disease (Cohort 2)
  • Received EGFR TKI treatment within 2 weeks
  • Treatment with any approved systemic anti-cancer therapy or systemic immune-stimulatory agents (including but not limited to interferons, interleukin IL-2, and tumor necrosis factor) within 28 days prior to initiation of study treatment.
  • Clinically uncontrolled pleural effusion or ascites that requires pleurocentesis or abdominal tapping for drainage within 2 weeks prior to initiation of study treatment.
Show all 28Show fewer
  • Active leptomeningeal disease or uncontrolled brain metastasis.
  • History of allergic reactions to any study drugs.
  • CrCl < 45 mL/min
  • Patients with active viral hepatitis that requires treatment.
  • Active autoimmune diseases that requires treatment and may affect study treatment estimated by investigator.
  • Any condition that required systemic treatment with either corticosteroids or any other immunosuppressive medication that may affect study treatment estimated by investigator.
  • Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy.
  • History of hemoptysis, i.e., coughing up at least one-half teaspoon of fresh blood, within 3 months prior to enrollment. (Cohort 2)
  • Imaging shows tumor invasion of a large vessel (e.g., pulmonary artery or superior vena cava) that the investigator determines is at risk for bleeding. (Cohort 2)
  • Had minor surgical procedures, such as tube placement, within 48 hours prior to first bevacizumab treatment. (Cohort 2)
  • Recently treated with a full dose oral or parenteral anticoagulant or thrombolytic agent. Prophylactic using anticoagulants is allowed. (Cohort 2)
  • History or test results indicating an inherited bleeding tendency or coagulation disorder that may increase the risk of bleeding (cohort 2)
  • uncontrolled hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg) (cohort 2)
  • Clinically meaningful (e.g., active) cardiovascular disease that, in the judgment of the investigator, is intolerant to bevacizumab therapy (cohort 2)
  • Non-cured wound, peptic ulcer in active phase, or fracture (cohort 2)
  • History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess or thrombotic disease within 6 months judged by the investigator to be intolerant to bevacizumab treatment (Cohort 2)
  • With a history of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung diseases, etc.
  • Have known human immunodeficiency virus (HIV) infection.
  • Any major surgical procedure requiring general anesthesia ≤ 28 days before initiation of study treatment.
  • Underlying medical conditions (including laboratory abnormalities) or alcohol or drug abuse or dependence that would be unfavorable for the administration of study drug or affect the explanation of drug toxicity or AEs (Adverse Events) or result in insufficient or might impair compliance with study conduct.
  • Concurrent participation in another clinical study.
  • Pregnant or lactating women, or male and female patients who plan to have children during the study period. -

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200000

    Baohui Han, 8618930858216, 18930858216@163.com

    Recruiting

Other trials in China

About this study

Official title: A Phase II Two Cohorts Prospective Study to Evaluate the Efficacy and Safety of Tislelizumab Combined With Chemotherapy With or Without Bevacizumab in Non-squamous NSCLC With EGFR Sensitizing Mutation Who Failed EGFR TKI Therapy

A phase II, open-label, multicenter, two cohorts, prospective clinical study to investigate the efficacy and safety of tislelizumab (anti-pd1 antibody) combined with chemotherapy with or without bevacizumab in non-squamous non-small cell lung cancer patients with EGFR sensitizing mutation who failed EGFR TKI (Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor) therapy.

Read the detailed description

Although EGFR tyrosine kinase inhibitors (TKI) have improved the survival of EGFR mutated NSCLC pts, drug resistance inevitably develops in almost all pts. Tislelizumab (tis), an anti-PD-1 mAb, has shown improved efficacy when combined with chemotherapy in pts with advanced EGFR-wt NSCLC with a tolerable safety profile. This study aims to evaluate the efficacy and safety of tislelizumab plus carboplatin and Nab-paclitaxel（cohort 1）or tislelizumab plus Nab-paclitaxel and bevacizumab （cohort 2） in EGFR-mut nsq-NSCLC pts failed to EGFR TKI therapies.

Keywords
Tislelizumab, PD-1, Chemotherapy, EGFR mutation, Non small cell lung cancer, Bevacizumab
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TislelizumabDrug

    Also called BGB-A317

    Tislelizumab 200mg administered intravenously (IV) on Day 1 of each 21-day cycle

  • CarboplatinDrug

    Carboplatin AUC 5 administered intravenously (IV) on Day 1 of each 21-day cycle, 4 cycles

  • PemetrexedDrug

    Pemetrexed 500mg/m2 administered intravenously (IV) on Day 1 of each 21-day cycle

  • BevacizumabDrug

    Bevacizumab 7.5mg/kg administered intravenously (IV) on Day 1 of each 21-day cycle

  • Nab paclitaxelDrug

    Nab-paclitaxel 260mg/m2 administered intravenously (IV) on Day 1 of each 21-day cycle, 4 cycles

Study groups in NCT04405674
Study groupRoleWhat they receive
Tislelizumab plus chemotherapyExperimentalTislelizumab plus Carboplatin/Nab-paclitaxel as induction treatment and followed by Tislelizumab plus pemetrexed as maintenance treatment.
Receives: Drug: Tislelizumab; Drug: Carboplatin; Drug: Pemetrexed; Drug: Nab paclitaxel
Tislelizumab plus chemotherapy plus BevacizumabExperimentalTislelizumab plus Nab-paclitaxel and Bevacizumab as induction treatment and followed by Tislelizumab plus Bevacizumab as maintenance treatment.
Receives: Drug: Tislelizumab; Drug: Bevacizumab; Drug: Nab paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1-Year Progression-Free Survival Rate (1-Year PFS Rate)

    Progression-free survival (per RECIST 1.1) is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first. Subjects who do not have disease progression will be censored at their last valid tumor assessment. PFS rate at 1 year as estimated by Kaplan-Meier method.

    Measured: up to 24 months after enrollment or study close

Secondary outcomes (5)

  1. Progression-Free Survival (PFS)

    Progression-free survival (PFS per RECIST 1.1) is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first.

    Measured: up to 24 months after enrollment or study close

  2. Objective Respond Rate (ORR)

    ORR (per RECIST 1.1) is defined as the proportion (%) of patients with at least one visit response of complete response (CR) or partial response (PR).

    Measured: up to 24 months after enrollment or study close

  3. Disease Control Rate (DCR)

    DCR (per RECIST 1.1) is defined as the proportion (%) of patients with at least one visit response of complete response (CR) or partial response (PR), or stable disease (SD).

    Measured: up to 24 months after enrollment or study close

  4. Overall Survival (OS)

    OS is defined as the time from the starting date of study drug to the date of death due to any cause.

    Measured: up to 24 months after enrollment or study close

  5. Duration of Response (DoR)

    DoR (per RECIST 1.1) is defined as the time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.

    Measured: up to 24 months after enrollment or study close

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2020
  2. Study start15 Jul 2020
  3. Primary completionApr 2022 (estimated)
  4. Study completionMar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04405674
Sponsor's protocol ID
BGB-A317-2001-IIT
Status last verified
Nov 2021
First submitted
25 May 2020
Last updated
22 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tislelizumab, Carboplatin and Pemetrexed in people with Non Small Cell Lung Cancer, run by Shanghai Chest Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-Year Progression-Free Survival Rate (1-Year PFS Rate) (time frame: up to 24 months after enrollment or study close). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04405674.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.

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